The Role of Health Equipment Directorate Supervision and Household Health Supplies Over Legal Importing Protection

Abstract

Fulfilling the need for medical devices in Indonesia does not come from domestic production. However, this device has purchased to another country (imports). The new era of globalization and free trade at ASEAN Economic Community has increased during the opportunity. Here, the development country needs to help for purchasing purpose of medical device products with the resulting of increasing number and types of imported medical devices circulating in Indonesia. Currently, the number of imported medical devices reaches 92% and the remaining 8% is domestic products (data from the health ministry's medical device info website). The importation of medical devices can only be carried out by business actors who already have a medical device distribution certificate / medical device distribution permit (permit to distribute medical devices) and medical device distribution permit (permit to distribute medical device products) issued by the Indonesian Ministry of Health. Thus, in this study aimed to analyse the process of importing medical devices if the business actor had exclusive rights of the product that has been registered with the Indonesian Ministry of Health or in this case, the owner of the distribution permit. The problem that often occurs is when the distribution permit owner is disadvantaged over the circulation of medical device products that should only be imported by the distribution permit owner, however in reality, the medical device products can be circulated by companies that are not exclusive rights holders. This research examines the legal protection carried out by the directorate of medical device supervision and medical supplies to the owner of a medical device distribution permit in dealing with imported medical devices not by the distribution permit owner.